IBRANCE Hard capsule (2023)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
IBRANCE 75 mg hard capsules. IBRANCE 100 mg hard capsules. IBRANCE 125 mg hard capsules.
Qualitative and quantitative composition
IBRANCE 75 mg hard capsules Each hard capsule contains 75 mg of palbociclib. <u>Excipients with known effect:</u> Each hard capsule contains 56 mg of lactose (as monohydrate). IBRANCE 100 mg hard capsules ...
Pharmaceutical form
Hard capsule. <u>IBRANCE 75 mg hard capsules:</u> Opaque, hard capsule, with a light orange body (printed PBC 75 in white) and a light orange cap (printed Pfizer in white). The capsule length is 18.0 ± ...
Therapeutic indications
IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer: in combination with an aromatase ...
Posology and method of administration
Treatment with IBRANCE should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Posology The recommended dose is 125 mg of palbociclib once daily for 21 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Use of preparations containing St. Johns Wort (see section 4.5).
Special warnings and precautions for use
Pre/perimenopausal women Ovarian ablation or suppression with an LHRH agonist is mandatory when pre/perimenopausal women are administered IBRANCE in combination with an aromatase inhibitor, due to the ...
Interaction with other medicinal products and other forms of interaction
Palbociclib is primarily metabolised by CYP3A and sulphotransferase (SULT) enzyme SULT2A1. <em>In vivo</em>, palbociclib is a weak, time-dependent inhibitor of CYP3A. Effects of other medicinal products ...
Fertility, pregnancy and lactation
Women of childbearing potential / Contraception Females of childbearing potential who are receiving this medicinal product, or their male partners should use adequate contraceptive methods (e.g., double-barrier ...
Effects on ability to drive and use machines
IBRANCE has minor influence on the ability to drive and use machines. However, IBRANCE may cause fatigue and patients should exercise caution when driving or using machines.
Undesirable effects
Summary of the safety profile The overall safety profile of IBRANCE is based on pooled data from 872 patients who received palbociclib in combination with endocrine therapy (N=527 in combination with letrozole ...
Overdose
In the event of a palbociclib overdose, both gastrointestinal (e.g., nausea, vomiting) and haematological (e.g., neutropenia) toxicity may occur and general supportive care should be provided.
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antineoplastic agents, protein kinase inhibitors <b>ATC code:</b> L01EF01 Mechanism of action Palbociclib is a highly selective, reversible inhibitor of cyclin-dependent ...
Pharmacokinetic properties
The pharmacokinetics of palbociclib were characterised in patients with solid tumours including advanced breast cancer and in healthy volunteers. Absorption The mean C<sub>max</sub> of palbociclib is generally ...
Preclinical safety data
The primary target organ findings following single and/or repeat dosing included haematolymphopoietic and male reproductive organ effects in rats and dogs, and effects on bone and actively growing incisors ...
List of excipients
Capsule content: Microcrystalline cellulose Lactose monohydrate Sodium starch glycolate type A Colloidal anhydrous silica Magnesium stearate Capsule shell: Gelatin Red iron oxide (E172) Yellow iron oxide ...
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PVC/PCTFE/PVC/Al blister strip containing 7 hard capsules (one capsule per cell). Each carton contains 21 hard capsules (3 blister strips per pack) or 63 hard capsules (9 blister strips per pack). HDPE ...
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Marketing authorization number(s)
<u>IBRANCE 75 mg hard capsules:</u> EU/1/16/1147/001 EU/1/16/1147/002 EU/1/16/1147/007 <u>IBRANCE 100 mg hard capsules:</u> EU/1/16/1147/003 EU/1/16/1147/004 EU/1/16/1147/008 <u>IBRANCE 125 mg hard capsules: ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 09 November 2016 Date of latest renewal: 16 July 2021
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